BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACRODUCT

    MDR report key: 871066 · Received June 19, 2007

    Report

    Report Number
    871066
    Event Type
    Malfunction
    Date Received
    June 19, 2007
    Date of Event
    June 7, 2007
    Report Date
    June 19, 2007
    Manufacturer
    WESCOR, INC.
    Product Code
    CGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SEEN FOR A SWEAT CHLORIDE TEST. THE CAUSE IS UNKNOWN, HOWEVER PATIENT SUSTAINED AN INJURY TO HIS ARM WHERE THE PILOGEL DISC/ELECTRODE WAS PLACED TO PERFORM THE TEST. THIS REACTION WAS DISCOVERED AFTER THE FIVE-MINUTE SWEAT STIMULATION WAS COMPLETED AND PILOGEL DISC WAS REMOVED. PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT. IT WAS NOTED THAT THE PATIENT HAD A 2-3MM LESION THAT WAS DARK IN COLOR AND APPEARED TO BE CONSISTENT WITH A BURN. THE MARCODUCT SYSTEM WAS EVALUATED BY THE BIOMED DEPARTMENT AND DETERMINED TO OPERATE AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACRODUCT SWEAT COLLECTION SYSTEM CGZ WESCOR, INC. 3700 *
    2 MACRODUCT SWEAT COLLECTION SYSTEM KTB WESCOR, INC. 3700-SYS *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY